- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01209767
Cryolipolysis and Subcision for Treatment of Cellulite
December 1, 2021 updated by: Murad Alam, Northwestern University
Comparison of the Efficacy Between Cryolipolysis and Subcision for Treatment of Cellulite: A Prospective Randomized Control Trial.
This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite.
The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite.
It has previously been used for fat reduction on love handles or back fat.
During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures.
The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite.
Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite.
Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected.
The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
This study was a pilot study designed to determine feasibility of these procedures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine, Department of Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
- All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion Criteria:
- Pregnant or lactating
- Subjects who are unable to understand the protocol or to give informed consent.
- Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
- Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
- Subjects who have active skin disease or skin infection in treatment area.
- Subjects who are allergic to lidocaine or prilocaine.
- Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic).
- Subjects who have history of abnormal scarring.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cryolipolysis
|
During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures.
The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
|
Active Comparator: subcision
|
Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected.
The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
|
Active Comparator: Control
Areas with cellulite that had no treatment performed were considered the control arm.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.
Time Frame: 12 weeks
|
Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12).
They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance".
It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
September 24, 2010
First Posted (Estimate)
September 27, 2010
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
December 1, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU34401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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